Accu-Chek Solo micropump system with interoperable technology— 510(k) K213134
Substantially EquivalentRoche Diabetes Care GmbH
FDA 510(k) clearance K213134 for Accu-Chek Solo micropump system with interoperable technology, Substantially Equivalent on 2023-08-10. Applicant: Roche Diabetes Care GmbH.
Clearance details
- Applicant
- Roche Diabetes Care GmbH
- Product code
- Code QFG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mannheim, DE
Adverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.